MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA SYSTEM MAX ASPIRATION TUBING; NRY

Catalog Number PST2

Device Problems Hole In Material (1293); Device Damaged Prior to Use (2284); Out-Of-Box Failure (2311)

Patient Problem No Patient Involvement (2645)

Event Date 03/31/2016

Event Type  malfunction  

Manufacturer Narrative

Results: the suction connector to the penumbra system max aspiration tubing (tubing) was blocked.Conclusions: evaluation of the returned device revealed that the tubing suction connector was blocked.The tubing was connected to the aspiration pump and no vacuum was present.Further evaluation revealed that the suction connector to the tubing was blocked by the adhesive that was used to bond the connector to the tubing.The blocked suction connector likely prevented the vacuum pressure from being present during preparation.No further damage was observed on the tubing.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.

Event Description

During preparation for a thrombectomy procedure, the physician noticed that the penumbra system max aspiration tubing (tubing) had a hole and therefore, suction was not possible.The damaged tubing was found prior to use and was not used for the procedure.The procedure was completed using a new aspiration tubing.

• Brand Name: PENUMBRA SYSTEM MAX ASPIRATION TUBING
• Type of Device: NRY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• Manufacturer Contact: kathleen kidd ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 5621688
• MDR Text Key: 44123742
• Report Number: 3005168196-2016-00576
• Device Sequence Number: 1
• Product Code: NRY
• UDI-Device Identifier: 00814548012025
• UDI-Public: 00814548012025
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K151623
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/31/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 11/30/2018
• Device Catalogue Number: PST2
• Device Lot Number: F66376
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/25/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/31/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/09/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1